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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TAPERED CEMENT REAMER; KNEE INSTRUMENT : REAMERS
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DEPUY ORTHOPAEDICS INC US MBT REV TAPERED CEMENT REAMER; KNEE INSTRUMENT : REAMERS Back to Search Results
Model Number 2178-63-106
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the mbt conical reamer slipping in adapter, edges was rounded off.Needs replacement.No surgical delay.
 
Manufacturer Narrative
Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
MBT REV TAPERED CEMENT REAMER
Type of Device
KNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9637628
MDR Text Key189369879
Report Number1818910-2020-03238
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295096054
UDI-Public10603295096054
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2178-63-106
Device Catalogue Number217863106
Device Lot NumberA0108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2020
Date Manufacturer Received01/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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